In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
Seoul National University Hospital
Seoul, South Korea
Late luminal loss in the analysis segment
Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel
Time frame: 9 months
Late luminal loss in the inflation/in-stent segment
Time frame: 9 months
Target lesion/vessel revascularization, myocardial infarction
Time frame: 1, 2 years
Periprocedural myocardial infarction
Time frame: 3 days
% diameter stenosis in the analysis segment & in the inflation/in-stent segment
Time frame: 9 months
Neointimal volume, % neointimal volume, % volume obstruction
The above parameters will be assessed by IVUS
Time frame: 9 months
Time interval from device insertion to initiation of deployment
Time frame: 0 days
Stent thrombosis
Time frame: 1, 2 years
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